Key Highlights

  • Both dazodalibep dosing regimens met the primary endpoint at Week 48 in the OASIZ-301 study.
  • The 1,500 mg every four weeks regimen reduced systemic disease activity by 5.6 points, against 3.8 points for placebo.
  • The 3,000 mg every 12 weeks regimen showed a 5.2-point reduction, a placebo-adjusted difference of 1.4 points.
  • Full results are scheduled for presentation at ACR Convergence 2026.

Amgen (NASDAQ:AMGN) has reported positive results from its Phase 3 OASIZ-301 study of dazodalibep in patients with Sjögren's disease, an autoimmune condition with no treatment approved by the U.S. Food and Drug Administration. The findings, published on November 11, 2026, build on topline data the company shared in September. The trial's latest figures add detail on how the drug performed against placebo over 48 weeks, covering both the disease activity index and patient-reported symptoms. Sjögren's disease is an autoimmune disorder that can affect the glands responsible for tears and saliva, and it can also involve other organs. Treatments that address the broader systemic activity of the disease are therefore measured with specialized scales, which is the context for the study's primary measure.

Study Design and Disease Activity Results

OASIZ-301 was randomized, double-blind and placebo-controlled. Participants had a mean baseline score of 10.2 on the European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index, known as ESSDAI, which measures systemic involvement. Each dosing arm included 217 patients in the reported analysis.

The 1,500 mg every four weeks group recorded a least-squares mean reduction of 5.6 points, compared with 3.8 points for placebo. That is a difference of 1.8 points with an adjusted p-value below 0.001. The 3,000 mg every 12 weeks group recorded a reduction of 5.2 points, a difference of 1.4 points with an adjusted p-value of 0.010. Amgen said the treatment effect was visible as early as Week 4 and was sustained through Week 48.

The ESSDAI scale scores systemic disease activity across several organ domains, so a reduction on that scale indicates change beyond dryness alone. The 1.8-point and 1.4-point differences between each treatment arm and placebo are measured on that scale, which means they reflect the composite score rather than a single symptom.

Patient-Reported Dryness Outcomes

At Week 48, the 1,500 mg every four weeks regimen also improved patient-reported dryness relative to placebo. The placebo-adjusted change was 1.17 points on the dryness domain of the EULAR Sjögren's Syndrome Patient Reported Index, and 0.93 points on the dryness domain of the Diary for Assessing Sjögren's Patient Reported Index. Both results reached an adjusted p-value below 0.001.

Amgen also noted that the disease can affect organs such as the lungs, kidneys and nervous system, in addition to dry eyes and mouth, fatigue and joint pain. That range of symptoms adds to the difficulty of measuring change in the condition.

Patient-reported outcomes capture how people feel and function day to day, and they are often reviewed alongside clinical scores. The two dryness measures in the study are separate instruments, and the results on both reached statistical significance at Week 48 for the 1,500 mg regimen.

Regulatory Position and Next Steps

Sjögren's disease currently has no FDA-approved treatments, which gives the trial additional significance for the patient population. The full data will be presented in a late-breaking session, identified as LB22, at the American College of Rheumatology Convergence 2026.

Amgen said it plans to build on the findings as it advances a broader Phase 3 program for dazodalibep, a drug it has described as a potential first-in-class treatment for the disease.

Phase 3 programs are typically designed to confirm results across larger and more varied patient groups before regulatory filings are made. Amgen's description of a broader program indicates that additional studies are planned, although the update does not set out their scope or timing.

Why the Trial Matters for the Patient Population

Sjögren's disease often affects people for many years, and the absence of an approved treatment has left clinicians relying on symptom management. Any therapy that shows a measurable effect on systemic activity offers a new reference point for future trials and for discussions about treatment options.

The company described OASIZ-301 as the only global Phase 3 trial to show clinically meaningful improvements in systemic disease activity and patient-reported symptoms in this disease. That claim is the company's own, and it will be assessed by clinicians and regulators as the full data become available.

Final Word

The OASIZ-301 results show a statistically significant gap between dazodalibep and placebo on the primary disease activity measure at Week 48, for both dosing regimens. The higher-frequency schedule also showed improvement in dryness. The placebo-adjusted differences of 1.8 and 1.4 points on the ESSDAI scale are the figures that will receive closest attention when the full data are presented, together with safety information and the structure of the broader program. The results add detail to the clinical picture for a disease area where approved Options are not yet available.